Administering compositions for improved immune system functioning

ABSTRACT

The present disclosure relates to methods of administering a composition to a patient, particularly in the form of a dietary supplement, which addresses immune system deficiencies and promotes healthy immune system functioning. The present disclosure also related to compositions and methods for improving or boosting immune system functioning. The present disclosure further provides novel compositions for balancing immune response in human subjects.

FIELD OF THE INVENTION

The present invention is directed to compounds, particularly dietarysupplements, used for healthy immune system functioning. The presentinvention is also directed to methods for improving a person's immunesystem, as well as methods for formulating and administering asupplement to accomplish the same.

BACKGROUND OF THE INVENTION

Accordingly, there is a long-felt but unresolved need to address theseand other problems, which are the subject of the compositions andmethods described in detail herein.

SUMMARY OF THE INVENTION

The invention in embodiments relates to a compound, particularly in theform of a dietary supplement, which addresses immune system deficienciesand promotes healthy immune system functioning, and that otherwiseaddresses the shortcomings in the prior art. As disclosed in more detailin the Detailed Description, the present invention provides compositionsand methods for improving or boosting immune system functioning. Thepresent invention comprises novel compositions for balancing immuneresponse in human subjects.

More particularly, the compositions described herein have been shown toactivate B cells and strengthen the mucosal immune barrier whileactivating NK cell activity following consumption. The compositions havealso been shown to promote general health and favorable balance ofintestinal flora and promote ra more robust immune system responseduring seasonal variations. In preferred embodiments, these benefits arerealized within two hours following consumption of the composition.

The present disclosure also relates to methods of administering acomposition to an individual experiencing immune deficiencies. Methodsfor forming the compound are further described herein.

The composition disclosed herein may further comprise herbs andnutrients to specifically support intestinal health in human subjects,which is beneficial to healthy immune system functioning. Byadministering various herbs and nutrients, the patient's intestinalsystem improves, and intestinal health has been shown to improve immunesystem health. Further, the composition disclosed herein may provide oneor more herbals to provide broad-spectrum antiviral, antimicrobial,anti-inflammatory and neuroprotective benefits.

In varying embodiments, the composition further supports the reductionof pro-inflammatory cytokines commonly elevated during illness/sickness,including but not limited to interleukin (“IL”)-1b, IL-6 and TNF alpha.

The composition is preferably free of common allergens, such as milk,casein, egg, fish, shellfish, tree nuts, peanuts, wheat, gluten, cornand soybeans. The composition is preferably suitable for consumption byindividuals following a vegan and/or vegetarian diet. The compositionpreferably is devoid of artificial colors and preservatives.

In embodiments, the unique combination of the composition is preferablyadministered orally in the form of a capsule, tablet, powder or lozenge.The unique combination has synergistic advantages over previously knowncompositions, all proportioned to provide the most benefit to peopleaffected by the problems described above.

The composition is preferably comprised of a unique and novelformulation in predetermined amounts, and further provides benefitspreviously unexpected. In a preferred embodiment, the composition iscomprised of unique blend of the following components: a dried yeastfermentate, such as fermentate derived from natural Saccharomycescerevisiae; olive leaf extract, such as an extract standardized to 20%Oleuropeins; andrographis extract, which may be derived from both stemand leaf, such as standardized to 10% andrographolides;N-acetylcysteine; skullcap root extract, such as Scutellaria baicalensisGeorgi (including in root form) derived from 8-12:1 concentrate; and,Trans-Resveratrol, such as derived from 50 mg Polygonum cuspidatum. Invarying embodiments, the composition is comprised ofcombinations/sub-combinations of the foregoing. In embodiments, thecomposition may comprise additional components as described herein.

In one embodiment, the dried yeast fermentate is selected from EpiCor®dried yeast extract. EpiCor® is a registered trademark of Embria HealthSciences.

In embodiments, the composition comprises the following components andvariable quantities listed as follows:

-   -   1) EpiCor® Yeast Fermentate—between about 250 mg to 750 mg;    -   2) Olive Leaf 20% Extract—between about 100 mg and about 300 mg;    -   3) Andrographis Extract—between about 100 mg and about 300 mg;    -   4) N-acetylcysteine—between about 100 mg and about 300 mg;    -   5) Skullcap Extract—between about 50 mg and 150 mg;    -   6) Trans-Resveratrol—between about 12.5 mg and 200 mg;

In embodiments, the composition comprises:

-   -   1) 500 mg EpiCor® Yeast Fermentate (from natural Saccharomyces        cerevisiae);    -   2) 200 mg Olive Leaf 20% Extract (as standardized to 20%        Oleuropeins);    -   3) 200 mg Andrographis Extract (stem and leaf) (as standardized        to 10% andrographolides);    -   4) 200 mg N-acetylcysteine;    -   5) 100 mg Skullcap Root Extract (as Scutellaria baicalensis        Georgi (root) derived from 8-12:1 concentrate);    -   6) 25 mg Trans-Resveratrol (from 50 mg Polygonum cuspidatum);

In one embodiment, the composition is provided as a dietary supplement.In one embodiment, the composition is administered in the form of avegetable-based capsule, and two capsules are administered daily.

In another embodiment, the composition is administered in the form of apowder, a gummy chew, a tablet, a lozenge or a liquid extract.

In a preferred embodiment, the formulation is unflavored, but in furtherembodiments, the composition may contain one or more palatability agentsto favorably alter the taste of the composition for human consumption.

Methods for treatment of individuals with immune system deficiencies,including but not limited to any of the disorders or deficiencies of thehuman immune system, are also expressly provided in this disclosure.Methods for administering the supplement described herein are alsowithin the scope of the present disclosure.

In embodiments, methods of formulating the composition are alsodisclosed herein.

It is to be expressly understood that he above-described embodiments,objectives, and configurations are neither complete nor exhaustive. TheSummary of the Invention is neither intended, nor should it be construedas being representative of the full extent and scope of the presentinvention. Other advantages will be apparent from the disclosure of theinvention(s) contained herein.

Embodiments of the present invention are set forth in various levels ofdetail in the Summary of the Invention, and no limitation as to thescope of the present invention is intended by either the inclusion ornon-inclusion of elements in this Summary of the Invention. Additionalaspects of the present invention will be readily apparent from the viewof one of ordinary skill in the art.

DETAILED DESCRIPTION

Although the following text sets forth a Detailed Description ofnumerous different embodiments, it should be understood that the legalscope of the description is defined by the words of the claims set forthat the end of this disclosure. The Detailed Description is to beconstrued as exemplary only, and does not describe every possibleembodiment since describing every possible embodiment would beimpractical, if not impossible. Numerous alternative embodiments couldbe implemented, using either current technology or technology developedafter the filing date of this patent, which would be encompassed by thescope of the claims.

As used herein, references to “the present invention” or aspects thereofshould be understood to mean certain embodiments of the presentinvention and should not necessarily be construed as limiting allembodiments to a particular description.

As used herein, the phrases “at least one”, “one or more”, and “and/or”are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “oneor more of A, B, or C” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together.

Unless otherwise indicated, all numbers expressing quantities, amounts,dimensions, conditions, and so forth used in the specification andclaims are to be understood as being modified in all instances by theterm “about”.

The term “a” or “an” entity, as used herein, refers to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more” and “atleast one” can be used interchangeably herein.

The use of “including,” “comprising,” or “having” and variations thereofherein is meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Accordingly, the terms “including,”“comprising,” or “having” and variations thereof can be usedinterchangeably herein.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.Section 112(f). Accordingly, a claim incorporating the term “means”shall cover all structures, materials, or acts set forth herein, and allof the equivalents thereof. Further, the structures, materials, or actsand the equivalents thereof shall include all those described in thesummary of the invention, brief description of the drawings, detaileddescription, abstract, and claims themselves.

In varying embodiments described herein, the present invention relatesto a compound that improves or enhances immune system functioning orthat otherwise addresses immune deficiencies or disorders. Certainelements of the novel compounds and methods for formulating the same aredescribed in varying levels of detail herein.

In embodiments, the composition is comprised of the foregoing elements:

Dried Yeast Fermentate

In a preferred embodiment, the composition comprises at least a DriedYeast Fermentate (preferably derived from natural Saccharomycescerevisiae), between about 250 mg to 750 mg. In a more embodiment, thecomposition comprises between about 400 and 600 mg of EpiCor® YeastFermentate. In a most preferred embodiment, the composition comprisesabout 500 mg of EpiCor® Yeast Fermentate (derived from naturalSaccharomyces cerevisiae).

Olive Leaf Extract;

Olive Leaf Extract has been shown to have beneficial effect on the humanimmune system, particularly when taken in combination with the othercomponents described herein.

In a preferred embodiment, the composition comprises Olive Leaf 20%Extract, preferably standardized to 20% Oleuropeins, between about 100mg and about 300 mg. In a more preferred embodiment, the compositioncomprises between about 160 and 240 mg of Olive Leaf 20% Extract. In amost preferred embodiment, the composition comprises about 200 mg ofOlive Leaf 20% Extract (standardized to 20% Oleuropeins).

Andrographis Extract

Andrographis Extract has also been found to improve immune systemfunction. In a preferred embodiment, the composition comprisesAndrographis Extract, preferably as standardized to 10%andrographolides, between about 100 mg and about 300 mg. In a morepreferred embodiment, the composition comprises between about 160 and240 mg of Andrographis Extract. In a most preferred embodiment, thecomposition comprises about 200 mg of Andrographis Extract (asstandardized to 10% andrographolides).

N-acetylcysteine

In a preferred embodiment, the composition comprises N-acetylcysteinebetween about 100 mg and about 300 mg. In a more preferred embodiment,the composition comprises between about 160 and 240 mg ofN-acetylcysteine. In a most preferred embodiment, the compositioncomprises about 200 mg of N-acetylcysteine.

Skullcap Root Extract

In a preferred embodiment, the composition comprises Skullcap RootExtract between about 50 mg and 150 mg. In a more preferred embodiment,the composition comprises between about 80 and 120 mg of Skullcap RootExtract. In a most preferred embodiment, the composition comprises about100 mg of Skullcap Root Extract, preferably as Scutellaria baicalensisGeorgi (in root form) derived from 8-12:1 concentrate.

Trans-Resveratrol

Trans-Resveratrol has been found through experimentation to providesignificant benefits to immune system functioning, particularly whenprovided in combination with the foregoing components. Resveratrolsignificantly reduces inflammatory cytokines that may reduce insulin andother natural productions of the human body. Further, Resveratrol hasbeen found to assist in the balancing of healthy cholesterol ratios andreduce cardiovascular complications in human subjects.

Resveratrol is a powerful antioxidant, may reduce pain, fatigue andswelling, and may reduce the risk of cancer in human subjects.Resveratrol has also shown special benefits to individuals who alsosuffer from diabetes, are at risk of diabetes, or exhibit pre-diabeticsymptoms.

Polygonum cuspidatum is the botanical name of Japanese knotweed, whichin a preferred embodiment is provided as the form of the compound“Resveratrol.” This particular form assists with protection of ACE 2receptors in the lungs, a known attachment site for Coronavirus andother viral infections, which enables rapid spreading.

In a preferred embodiment, the composition comprises between about 12.5mg and 200 mg of Trans-Resveratrol, preferably from Polygonumcuspidatum. In a more preferred embodiment, the composition comprisesbetween about 15 and 50 mg of Trans-Resveratrol. In a most preferredembodiment, the composition comprises about 25 mg of Trans-Resveratrol(from Polygonum cuspidatum).

Absent Elements

In addition, the composition of a preferred embodiment is substantiallyfree of the following common allergens: milk, casein, gluten, wheat,eggs, peanuts, tree nuts, dairy, corn, soybeans, sugar andfish/shellfish. The composition preferably does not contain artificialcolors, flavors, or preservatives, and is free from magnesium stearate(a common lubricant used in the manufacture of pharmaceuticals anddietary supplements).

Additional Elements

In varying embodiments, the composition can further comprise variances,particularly with respect to encapsulation and/or powder formulations.According to certain embodiments, the compositions described herein canfurther be provided with one or more palatability agents. Thesepalatability agents serve to add flavor to the composition so that aneffective dosage is easier to be ingested. It is within the scope of thepresent invention that any safe, flavor enhancing palatability agent canbe used in a composition of the present invention. Particularly suitablepalatability agents for use in the composition of the present inventioninclude, but are not limited to, plant oils, plant hydrolysates, yeast,yeast hydrolysates, and combinations thereof.

Methods

An aspect of the invention is a method to treat a patient experiencingvision impairment, blurry vision, dry eyes, presbyopia, macular edema,cataracts, glaucoma, macular degeneration and temporal arteritis, amongother conditions, with a composition comprising a unique combination andblend of Dried Yeast Fermentate (from natural Saccharomyces cerevisiae),Olive Leaf Extract (as standardized to 20% Oleuropeins), AndrographisExtract (as standardized to 10% andrographolides), N-acetylcysteine,Skullcap Extract (as Scutellaria baicalensis Georgi derived from 8-12:1concentrate), and Trans-Resveratrol (from Polygonum cuspidatum), orcombinations/sub-combinations thereof. According to one embodiment,during administration the patient is treated by providing an effectiveamount of the composition. In certain embodiments, the composition canbe taken by the patient daily, with no regard to meals or time of dayingested. In a preferred embodiment, the composition is administeredapproximately 30 minutes prior to consumption of daily meals, or morethan 2 hours following the patient's last meal. In one such embodiment,the composition is administered in the form of a capsule or two capsulesthat are fit for human consumption.

According to another embodiment, a method to prepare a compound isdisclosed. The components are mixed in a proprietary blend and may beprovided in a delivery device, for example, in the form of a capsule,tablet, lozenge or powder. The foregoing detailed description of thepreferred embodiments is incorporated by reference in this portion ofthe specification.

While various embodiments of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims. Ranges have been discussed and used within theforgoing description. One of skill in the art will understand that anysub-range within the stated range would be suitable, as would any numberwithin the broad range, without deviating from the spirit of the presentinvention.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment.

The invention claimed is:
 1. A method of treating a patient with animmune system deficiency, comprising: administering to the patient witha capsule, wherein the capsule comprises: from about 250 to 750 mcg ofYeast Fermentate; from about 100 to 300 mg the Olive Leaf Extract; andfrom about 100 to 300 mg of Andrographis Extract; from about 100 to 300mg N-acetylcysteine; from about 50 to 150 mg Skullcap Root Extract; andfrom about 12.5 to 200 mg Trans-Resveratrol, wherein the immune systemdeficiency is Hashimoto's disease.
 2. The method of claim 1, wherein thecomposition is administered to the patient in the form of a dietarysupplement.
 3. The method of claim 1, wherein the composition isadministered to the patient in the form of an acid resistant capsule. 4.The method of claim 1, wherein the composition is administered orally inthe form of a tablet.
 5. The method of claim 1, wherein the compositionadministered to the patient further comprises a palatability agent. 6.The method of claim 5, wherein the palatability agent is at least one ofa plant oil, plant hydrolysates, yeast, and yeast hydrolysates, andcombinations thereof.
 7. The method of claim 1, wherein the compositionadministered to the patient does not include milk, casein, gluten,wheat, eggs, peanuts, tree nuts, dairy, corn, soybeans, sugar andfish/shellfish.
 8. The method of claim 1, wherein the Trans-resveratrolis provided in the form of Polygonum cuspidatum.
 9. A method ofimproving immune system functioning in a patient exhibiting disordersrelating to the same, wherein the method comprises administering acomposition consisting essentially of: 500 mg of Dried Yeast Fermentate;200 mcg of Olive Leaf Extract; 200 mg of Andrographis Extract; 200 mg ofN-acetylcysteine; 100 mg of Skullcap Root Extract; and 25 mg ofTrans-Resveratrol; wherein the patient is exhibiting Hashimoto'sdisease.
 10. The method of claim 9, wherein the Trans-Resveratrol isselected from 50 mg Polygonum cuspidatum.
 11. The method of claim 9,wherein the composition administered to the patient is devoid of thefollowing: milk, casein, gluten, wheat, eggs, peanuts, tree nuts, dairy,corn, soybeans, sugar and fish/shellfish.
 12. The method of claim 9,wherein the composition is administered to the patient in the form of adietary supplement.
 13. The method of claim 9, wherein the compositionis administered to the patient in the form of an acid resistant capsule.14. The method of claim 9, wherein the composition is administeredorally in the form of a tablet.
 15. The method of claim 9, wherein thecomposition further comprises at least one palatability agent.
 16. Themethod of claim 15, wherein the palatability agent is at least one of aplant oil, plant hydrolysates, yeast, and yeast hydrolysates, andcombinations thereof.